BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK VAPR ANGLED SIDE EFFECT ELECTRODE, 21 DEGREE

    MDR report key: 3870567 · Received June 12, 2014

    Report

    Report Number
    1221934-2014-00248
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 15, 2014
    Manufacturer
    DEPUY MITEK
    Product Code
    GEI
    PMA / PMN Number
    K974022
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS HAVE BEEN MADE TO RETRIEVE ADDITIONAL INFORMATION ABOUT THE EVENT AND DEVICE. THE ADDITIONAL INFORMATION WILL REPORTEDLY BE FORWARDED TO DEPUY MITEK; HOWEVER, IT IS NOT KNOWN IF IT WILL BE RECEIVED WITHIN THE 30 DAY REPORTING REQUIREMENT, THEREFORE, DEPUY MITEK WOULD LIKE TO FILE THIS INITIAL MEDWATCH REPORT AT THIS TIME. WHEN AND IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REFLECTED IN A FOLLOW-UP MEDWATCH REPORT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RECEIVED AND TESTED. VISUAL OBSERVATION REVEALS NO ANOMALIES ON THE ACTIVE TIP. THE ELECTRODE WAS CONNECTED TO A VAPR VUE GENERATOR AND ALL CORRECT DEFAULT SETTINGS WERE MADE AVAILABLE. THE GENERATOR WAS SET TO MAXIMUM POWER FOR ABLATION AND COAGULATION MODES AND ACTIVATED IN SALINE SUCCESSFULLY INDICATING THAT THE DEVICE WAS FIT FOR FUNCTION AT THE TIME OF USE. THE ELECTRODE WAS TESTED SEVERAL TIMES TO ENSURE CONTINUITY OF FUNCTION. THERE WERE NO ISSUES IDENTIFIED IN THE FUNCTION OF THE DEVICE. THE IFU STATES: ¿OBSERVE EXTREME CAUTION WHEN USING ELECTRO SURGERY IN CLOSE PROXIMITY TO OR IN DIRECT CONTACT WITH ANY METAL OBJECTS. THE MAJORITY OF ARTHROSCOPES AND ARTHROSCOPIC INSTRUMENTS ARE METAL. DO NOT ACTIVATE THE ELECTRODE WHILE ANY PORTION OF THE ELECTRODE AND THE ADJACENT METAL OBJECT MAY RESULT IN PRODUCT DAMAGE.¿ OPERATING THE ELECTRODE IN CLOSE PROXIMITY OF THE SCOPE IS CONTRARY TO THE PRECAUTIONS STATED IN THE IFU. IT WAS UNDETERMINED WHICH LOT THE ELECTRODE BELONGED TO AND THEREFORE A LOT REVIEW WAS PERFORMED ON TWO POSSIBLE LOTS. LOT REVIEW RESULTS INDICATED THAT BOTH BATCHES OF PRODUCT WERE PROCESSED WITHOUT INCIDENT AND THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. FURTHER, A REVIEW INTO THE DEPUY MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS FROM EITHER LOTS THAT WERE RELEASED TO DISTRIBUTION. A ROOT CAUSE FOR THE REPORTED FAILURE CANNOT BE DISCERNED. BASED ON THE COMPLAINT HISTORY FOR THIS FAILURE, AT THIS POINT, NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

    Description of Event or Problem · 1

    THE PRODUCT WAS CONNECTED TO VAPR3 SYSTEM. IT WAS NOTED DURING THE SURGERY THAT AN ALARM DID NOT ACTIVATE, BUT INSTEAD, THE DISPLAY WAS BLACKED OUT FOR A SECOND WHEN THE DEVICE WAS PLACED CLOSED TO THE SCOPE. THE ELECTRODE USED AT THE SURGERY WAS BRAND NEW DEVICE. THE DEVICE WAS REPLACED TO ANOTHER ELECTRODE AND COMPLETED THE CASE WITHOUT PROBLEM. THERE WERE NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCES TO THE PATIENT. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED FROM OUR AFFILIATE ON 5-22-14; I HAVE CONFIRMED WITH THE REP THAT IT WAS THE VIDEO MONITOR NOT THE GENERATOR.

    Description of Event or Problem · 1

    THE PRODUCT WAS CONNECTED TO VAPR3 SYSTEM. IT WAS NOTED DURING THE SURGERY THAT AN ALARM DID NOT ACTIVATE, BUT INSTEAD, THE DISPLAY WAS BLACKED OUT FOR A SECOND WHEN THE DEVICE WAS PLACED CLOSED TO THE SCOPE. THE ELECTRODE USED AT THE SURGERY WAS BRAND NEW DEVICE. THE DEVICE WAS REPLACED TO ANOTHER ELECTRODE AND COMPLETED THE CASE WITHOUT PROBLEM. THERE WERE NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCES TO THE PATIENT. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED FROM OUR AFFILIATE ON (B)(4) 2014; I HAVE CONFIRMED WITH THE REP THAT IT WAS THE VIDEO MONITOR NOT THE GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348842 MITEK VAPR ANGLED SIDE EFFECT ELECTRODE, 21 DEGREE ELECTROSURGICAL: CUTTING AND COAGULATING GEI DEPUY MITEK NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1